rosiglitazone in treating patients with locoregionally extensive or metastatic thyroid cancer

Conditions: Head and Neck Cancer

Summary: rationale: drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine. purpose: this phase ii trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer.

objectives: primary * determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone. secondary * compare the long-term response of patients treated with this drug with historical controls. * determine the toxicity profile of this drug in these patients. * determine the presence/persistence of tumor in patients treated with this drug. * determine the quality of life of patients treated with this drug. * determine overall survival of patients treated with this drug. outline: this is a pilot study. patients receive oral rosiglitazone once daily on weeks 1-8. patients also receive oral liothyronine sodium twice daily on weeks 1-6 in preparation for radioactive iodine scan. treatment continues in the absence of disease progression or unacceptable toxicity. at week 8, all patients undergo whole body radioactive iodine scan followed by a treatment dose of radioiodine to assess radioiodine uptake by tumor. quality of life is assessed at baseline and at the end of study treatment. patients are followed at 2 weeks, 1, 4, and 10 months, and then every 6 months for 1 year. projected accrual: a total of 20-25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of differentiated thyroid cancer * locoregionally extensive and/or metastatic disease * inoperable disease * failed prior conventional therapy that included total/near-total thyroidectomy and radioactive iodine i 131 ablation therapy * elevated thyroglobulin (tg) levels (\> 3 ng/ml on thyroid hormone or \> 10 ng/ml off thyroid hormone) * tg-antibody positive patients are eligible despite the tg level * radioactive iodine (rai) scan showing no or therapeutically insignificant (\< 1%) rai uptake after thyroid hormone withdrawal * scan performed within the past 18 months patient characteristics: age * 18 and over performance status * not specified life expectancy * not specified hematopoietic * hemoglobin ≥ 10 g/dl * wbc ≥ 3,000/mm\^3 * platelet count ≥ 50,000/mm\^3 hepatic * alt ≤ 2 times upper limit of normal renal * creatinine ≤ 1.5 mg/dl cardiovascular * no new york heart association class iii or iv cardiac disease other * not pregnant * no nursing within the past 3 months * negative pregnancy test * fertile patients must use effective contraception * no allergy to thiazolidinediones * no other malignancy except basal cell skin cancer prior concurrent therapy: biologic therapy * not specified chemotherapy * more than 3 months since prior chemotherapy endocrine therapy * see disease characteristics * no concurrent levothyroxine radiotherapy * see disease characteristics * no prior cumulative dose of radioiodine ≥ 800 mci * prior adjuvant or therapeutic external beam radiotherapy allowed surgery * see disease characteristics

Keywords: recurrent thyroid cancer stage ii follicular thyroid cancer stage iv follicular thyroid cancer stage ii papillary thyroid cancer stage iv papillary thyroid cancer